Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The object of this study is to compare the effect of PRP versus Corticosteroid injection on pain in patients with Greater Trochanteric Pain Syndrome up to 12 months after treatment. It is believed that PRP will be as good as corticosteroids for short term pain relief, and will produce longer lasting pain reduction.
详细描述
The purpose of this study is to compare the efficacy of Platelet Rich Plasma (PRP) injections versus Corticosteroid injections in treating patients that have failed noninvasive management for Greater Trochanteric Pain Syndrome (GTPS). We will be comparing in both the short term (0-6 months) and in the long term (6-12 months). It will be a Double-Blinded Randomized Clinical Trial. Patients with GTPS will be randomly assigned to either the Corticosteroid group or PRP group. There will be a total of 50 participants enrolled with 25 in each group. The PRP group will receive 3 mL of autologous plasma injection into the area of tendinopathy utilizing ultrasound guidance. One (1) injection per month will be administered for a total of three (3) injections. The Corticosteroid Group will receive 2.0 mL's injection of lidocaine and 40mg of Triamcinolone into the area of tendinopathy utilizing ultrasound guidance on their first injection. They will then receive 2.0 mL's of 1% lidocaine and 3.0 mL's of 0.9% Sodium Chloride per month for a total of three (3) injections. Both groups will be referred to physical therapy. Participant's pain will be assessed using a Visual Analog Scale (VAS) and the Nonarthritic Hip Score (NHS) for function at the beginning of the treatment and then again at 1, 3, 6, 9, and 12 months after the initial injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ages 18 and older.
- •Active duty soldiers and military health care beneficiaries.
- •Have lateral hip pain in the region of the greater trochanter for at least 6 weeks and have done physical therapy.
- •Reproducible pain on palpation of the greater trochanteric region.
- •Tendinopathy diagnosed with ultrasound. The criteria is as follows: a well-defined hypoechoic area with partial tear or complete tendon rupture that is suggestive of a tendon tear. A hyperechoic intratendinous area with posterior acoustic shadowing suggestive of a calcification, or both
排除标准
- •Received corticosteroid for the condition in last 6 months.
- •History of surgery in affected hip.
- •Allergy to Lidocaine.
- •Allergy to Corticosteroid.
- •Unavailable for follow up by telephone for 12 months after initial injection.
- •Patients with broken skin or skin infections immediately overlying the area to be injected.
- •Patients with complete tears of the gluteal tendons with retraction of the muscle and or tendon, as determined by ultrasound.
- •If they are pregnant or planning on becoming pregnant during the study time. Because of the physiologic changes during pregnancy we cannot predict how Corticosteroids will affect the mother and the infant. Also, this will increase stress to an already immunocompromised state.
- •Have not attended formal physical therapy
研究组 & 干预措施
Corticosteroid
干预措施: Triamcinolone Acetonide (Drug)
Platelet Rich Plasma
干预措施: Platelet Rich Plasma (Other)
结局指标
主要结局
Pain
时间窗: 1 year
Will use Visual Analog scale to measure overalll pain at 0, 1, 3, 6, 9, and 12 months of both groups to compare efficacy of both treatments.
次要结局
- Functional outcomes(1 year)
研究者
MAJ Aaron Williams
Family/Sports Medicine Staff, Family Medicine Residency Center
C.R.Darnall Army Medical Center